Malaysia medical device QA/RA blog

News and commentary on regulatory changes.

New Medical Device Classification Criteria from Malaysian MDA


  • The Malaysian MDA has introduced a formal process to determine whether a health product is considered a medical device.
  • The MDA uses four key criteria, including intended use, to determine if a product should be classified as a device.
  • Companies may submit applications to the MDA to obtain official classification decisions regarding their products.

Malaysia MDA medical device classification guidelines 2016The Medical Device Authority (MDA), Malaysia’s medical device market regulator, has published new guidelines for determining whether a product qualifies as a device.

The new guidelines identify four key criteria that the MDA will use to assess classification of health products as devices or drugs:

  • The product’s primary intended use or purpose
  • The product’s primary mode of action to achieve the intended effect; devices achieve their effects through physical or mechanical actions, while drugs do so via pharmacological, metabolic or related actions
  • The product’s active ingredients, indications and/or dosage forms, which constitute key criteria for pharmaceutical products
  • How regulators in reference countries (The US, European Union, Canada, Australia and Japan) classify identical or similar products

The MDA has also established a process whereby Malaysian market registrants may request official classification determinations from the regulator.

For more information on the Malaysian medical device market, read our whitepaper and download our regulatory process chart.





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